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adaptix interbody system with titan nanolock surface technology
Medtronic Sofamor Danek
Summary: The Adaptix Interbody System with Titan NanoLock Surface Technology is a spinal implant used in spinal fusion surgeries. It is primarily used by orthopedic surgeons and neurosurgeons to stabilize the spine and promote bone growth.
FDA Clearance Information
Pathway
510K
Number
K201267 ↗
Decision Date
August 26, 2020
Product Code
MAX
Device Class
Class 2
Evidence
0 studies
The Adaptix Interbody System was cleared through the FDA 510(k) pathway on August 26, 2020. It is manufactured by Medtronic Sofamor Danek and classified as a Class 2 device under product code MAX.
What It Is
The Adaptix Interbody System is a spinal implant designed to aid in spinal fusion procedures. It features Titan NanoLock Surface Technology, which enhances bone growth and integration by providing a textured surface that encourages cellular attachment. This device is used to replace damaged or degenerated intervertebral discs, providing stability and support to the spinal column.
Clinical Applications
This device is commonly used in spinal fusion surgeries, particularly in cases of degenerative disc disease, spondylolisthesis, or spinal stenosis. It is typically utilized in hospital operating rooms by orthopedic surgeons and neurosurgeons. The patient population includes adults with chronic back pain or spinal instability requiring surgical intervention.
Indications for Use
The FDA indications for the Adaptix Interbody System include use in patients requiring spinal fusion due to conditions such as degenerative disc disease or other spinal disorders. It is intended to provide stability and support to the affected spinal segment.
Practical Considerations
The Adaptix Interbody System comes in various sizes to accommodate different patient anatomies and surgical needs. It is compatible with standard surgical instruments used in spinal fusion procedures. Surgeons should be familiar with the specific implantation technique to ensure optimal outcomes.
Frequently Asked Questions
What is Adaptix Interbody System used for?
It is used in spinal fusion surgeries to stabilize the spine and promote bone growth in patients with conditions like degenerative disc disease.
What specialties typically use this device?
Orthopedic surgeons and neurosurgeons typically use this device in spinal fusion procedures.
What are the FDA-cleared indications?
The device is indicated for use in spinal fusion surgeries for conditions such as degenerative disc disease and spinal instability.
Disclaimer: This page compiles publicly available regulatory and published clinical evidence for educational reference.
It does not constitute medical advice, product endorsement, or a recommendation for clinical use.
Always consult manufacturer documentation and clinical judgment for patient care decisions.